Advances in Pharmacoepidemiology and Drug Safety

Ashish Jain

Ashish Jain, Curis Inc., Lexington, MA
Senior Director, Pharmacovigilance department
Lexington VA Medical Center, Lexington, MA, USA

Biography

SUMMARY: Trained pharmacist with 12+ years of experience in pharmacovigilance and risk management. Results-driven safety professional with expertise in analyzing and communicating safety information to drive informed decision-making across product life cycles, from development to post-marketing. • Senior Leadership Representation & Drug Safety departmental setup experience: Established internal operational practices and procedures for adverse event processing and reporting from clinical trials and postmarketing surveillance. Developed and implemented strategic plans for the Pharmacovigilance department with oversight of operational excellence and management of the safety requirements of product profiles. Represented the Pharmacovigilance department as a senior leader and provided managerial support to direct reports, including training and mentoring, which aligns with the overall responsibility of leading a highperforming team. • Signaling and Surveillance: Lead the SRT (Safety Review Committee) and presentations to the Safety Review Board (SRB) with cross-functional team members to conduct ongoing surveillance, including signal detection and evaluation, for multiple investigational products, and write up analysis results in collaboration with safety physician. Collaborated with clinical teams and, the Biostats team to summarize and discuss safety data for, Drug Monitoring Committees (DMC), Clinical Safety Committees and Drug Safety Monitoring Board (DSMB). • Aggregate reports: Lead the authoring, preparation, and review of comprehensive aggregate safety reports, including DSUR, (IND) Annual Reports, PSUR, and PBRER. Ensured timely submission of high-quality reports by coordinating with cross-functional teams. Developed and implemented standard operating procedures and work instructions to enhance report consistency and compliance with global regulatory guidelines. • Risk Management: Collaborated with physicians and implemented both routine and additional risk minimization measures, ensuring alignment with regulatory requirements. Created comprehensive risk management plans and strategies and revised them based on emerging safety information and regulatory feedback. Presented key risk management activities and findings at investigator meetings and training sessions, enhancing understanding and collaboration among clinical investigators and study teams. • Health Authority interactions & Regulatory compliance: Acted as the primary pharmacovigilance contact for interactions with health authorities, including the FDA, EMA, and other national agencies. Prepared and delivered clear, concise, and scientifically robust responses to health authority queries related to drug safety and risk management. Participated in multiple regulatory inspections as a Subject Matter Expert (SME) under the inspection readiness program, ensuring compliance with regulatory requirements. Ensured PV compliance as Process Owner, analyzing monthly compliance data to identify root causes of late cases and presenting compliance metrics in monthly reports. • Vendor oversight, SOPs and Process Excellence: Developed, updated, and refined SOPs through crossfunctional collaboration with SMEs, harmonizing processes and procedures based on best practices. Provided ongoing support to partners and vendors, conducting oversight and performance management on contracted work, including monitoring reports and quality evaluations. WORK EXPERIENCE: Curis Inc., Lexington, MA, USA. Senior Director, Pharmacovigilance and Risk Management Jun 2022 – Present Director, Pharmacovigilance and Risk Management May 2021 – June 2022 • Established a comprehensive safety surveillance system by developing and implementing robust SOPs and a well-defined governance framework. As the lead of the internal Safety Review Team (SRT), led a crossfunctional team of experts in reviewing and evaluating comprehensive safety data, risk-benefit assessments, and risk management strategies. Facilitated data-driven discussions and guided the safety review board (SRB) in making informed recommendations to ensure patient safety, maintain regulatory compliance, and align with overall company objectives. • Established the Pharmacovigilance department, including hiring of staff/consultants, developing SOPs, managing the Drug Safety & Pharmacovigilance budget, including long-term forecasts, and led the selection and management of safety vendors to support pharmacovigilance activities, ensuring quality and efficiency in external partnerships. • Provided critical insights to the Chief Medical Officer (CMO) and Executive Leadership Team (ELT) on the evolving risk-benefit profile of company products and competitor's products in clinical trials, leveraging indepth analyses and evaluation of potential safety signals. • Serve as a voting member of the External Protocol Review Committee (EPRC), a critical governance body responsible for evaluating and approving incoming requests for Investigator-Sponsored Trials (ISTs) and Investigator-Initiated Trials (IITs). • Responsible for all aspects of pharmacovigilance related to products in clinical trials including safety components of the study protocol, (RSI) IB, Clinical trial agreement (CTA), Investigational Medicinal Product Dossier (IMPD), informed consent form (ICF), clinical study report (CSR) participation in dose-escalation meetings, and Recommended Phase 2 dose (RP2D) selection. • Led the development, review, and timely submission of aggregate safety reports, including Development Safety Update Reports (DSURs), IND annual safety report (IND-SR), Benefit/Risk assessment with 6 monthly line listing of Suspected Unexpected Serious Adverse Reactions (SUSARs) and other relevant regulatory documents. • Provided strategic guidance for the safety sections of Regulatory Agency responses, Target product profiles (TPPs), IRB/EC requests, briefing books, public presentations, and journal/ manuscript scientific publications. • Led safety CRF development, safety monitoring plan, protocol review, coding review as well as SAE reconciliation activities. • Established CRO and vendor oversight procedures and Key Performance Indicators (KPIs) and provided feedback for continuous improvement to quality and timeliness of deliverables. • Direct the setup of safety procedures and development of safety data exchange agreements (SDEA) for codevelopment projects. Syros Pharmaceuticals, Cambridge, MA Associate Director, Drug Safety & Risk Management May 2019 – May 2021 • First PV person to be hired to initiate and develop the PV department. • Performed routine signal detection, assessment, and evaluation, presentation to the Safety Review Committee (SRC) and ensuring all processes were documented clearly and completed within required timelines. • Conducted comprehensive ongoing reviews of emerging safety data from diverse sources including single case reports, aggregate reports, clinical trials, and literature to identify potential safety issues. • Lead, coordinated, planned, and prepared key aggregate reports (e.g., DSUR, IND-SR, CSR) and other safetyrelated regulatory documents, adhering to regulatory guidelines and timelines. • Lead, presented, and participated in Safety Review Team (SRT) meetings, providing vital support in data analysis, scheduling, preparing agendas, and documenting meeting minutes. • Assisted in operations and compliance activities, including the implementation and management of Safety Management Plans (SMP) and Safety Data Exchange Agreements (SDEA). • Identified, selected, and managed Pharmacovigilance (PV) vendors to ensure adherence to PV case processing work instructions, improving overall safety operations. • Ensure SAE reconciliation is done in collaboration with data management and vendors as per the data management plan. • Subject matter expert (SME) for all strategic safety related material, including input and guidance for relevant authority safety-related questions; provide ad/hoc PV support & guidance for interdepartmental initiatives. • Preparation and review of Standard Operating Procedures (SOP) and work instruction documents. Curis Inc., Lexington, MA, USA. Senior Manager, Drug Safety Mar 2017 to May 2019 • First PV person to be hired to initiate and develop the PV department. • Spearheaded the implementation and centralization of a comprehensive safety database and safety operations for Curis, ensuring seamless transition from multiple CROs to a single safety vendor for all programs in development. This strategic initiative resulted in reduced costs through the implementation of innovative outsourcing models, streamlining processes, and enhancing efficiency. • Actively participated in the development of safety Case Report Forms (CRFs), safety monitoring plans, and protocol reviews. Provided critical support for Data Safety Monitoring Board (DSMB) activities, coding reviews, and Serious Adverse Event (SAE) reconciliation, ensuring the highest standards of data integrity and patient safety. • Collaborated closely with the medical team to provide valuable safety input into clinical development planning activities. Contributed expertise in the review and finalization of clinical protocols, Investigator's Brochures (IB), Informed Consent Forms (ICF), and other study-related documents, ensuring compliance with regulatory requirements and industry best practices. • Worked cross-functionally with internal departments, key stakeholders, and external resources on pharmacovigilance-related matters. Ensured strict adherence to global pharmacovigilance regulations and requirements, maintaining a robust safety reporting system and proactively identifying and mitigating potential risks. • Directed the establishment of safety procedures and the development of Safety Data Exchange Agreements (SDEA) for co-development projects. Collaborated with partners to define roles, responsibilities, and timelines, ensuring seamless data exchange and effective safety monitoring throughout the product lifecycle.